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Health Canada will make public information it has kept secret regarding serious, sometimes fatal side-effects suspected to have been caused by unapproved “off-label” prescriptions.

The announcement by the minister of health comes after an ongoing Star investigation exposed the federal regulator was scrubbing crucial information from public view.

The information — which showed whether a drug involved in a side-effect case had been prescribed for an unapproved use — was removed from side-effect reports before Health Canada published those reports in its online public database.

“I am committed to improve access to timely, useful and relevant health and safety information, including off-label use, so that Canadians can make informed choices,” Minister of Health Rona Ambrose told the Star in a statement.

Health Canada has collected the information for six years but blamed technical limitations with the database for preventing its public release. A spokeswoman said the regulator is upgrading its systems and will disclose the missing information once that is complete.

Neither Ambrose’s office nor Health Canada provided a timeline for when the records will be publicly available.

The Star had to go to the United States to find this crucial information about Canadian patients suffering suspected side-effects after they received unapproved treatments. We analyzed a massive trove of data found in the U.S. Food and Drug Administration’s public side-effect report database, which accepts reports from Canada and around the world.

Ambrose said the decision to release the prescription information is part of a greater initiative to make Health Canada “more open and transparent and communicate information with Canadians.”

“It is a step in the right direction,” said Sen. Art Eggleton, who was deputy chair of a Senate committee that recently investigated off-label prescribing and who wants Health Canada to do a better job of regulating drug safety.

“I hope this will be a fulsome disclosure. I hope it will reduce adverse effects (of drugs),” he said.

Health Canada said it will publish negative decisions it has issued for drugs seeking approval for new uses. This will allow doctors and patients to see whether an off-label treatment was in fact rejected by the regulator for safety concerns.

Off-label means a drug is being used for a condition or age group for which it has not been approved.

Doctors across Canada are routinely giving powerful drugs to vulnerable patients, often without strong scientific evidence that the drugs will be safe or effective, and sometimes despite warnings that such prescribing could cause serious harm.

In each case, there was no strong scientific evidence to justify the treatment. As well, the unapproved use was thought to have caused a side-effect. (Each side-effect report collected by health regulators is the opinion of the doctor, pharmacist or patient that a particular drug has caused a reaction.)

In some cases, the Star found Health Canada is not even reviewing all the troubling data it collects.

Health Canada, which has similar reports in its internal database, said it has not done any reviews of these cases and there are currently “no emerging safety issues requiring further assessment” of the drug’s use for morning sickness.

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